Trial Outcomes & Findings for Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies (NCT NCT02629692)
NCT ID: NCT02629692
Last Updated: 2026-05-13
Results Overview
PART C: Proportion of subjects achieving Major Cytogenetic Response \[ defined as complete cytogenetic response (CCyR; 0% Ph+metaphases) or partial cytogenetic response (PCyR; 1-35% Ph+ metaphases)\] as assessed by conventional Karyotyping of Bone marrow aspirate
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
124 participants
Primary outcome timeframe
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Results posted on
2026-05-13
Participant Flow
Part A comprised of 40 healthy subjects, Part B comprised of 61 patients and Part C comprised of 23 patients.
Participant milestones
| Measure |
Part A: Dose Level 1 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
|
Part A: Dose Level 2 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 12mg
|
Part A: Dose Level 3 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
|
Part A: Placebo (SAD Study)
Part A: Oral placebo capsules
|
Part A: Dose Level 1 (FE Study)
Part A: Oral vodobatinib (K0706) capsules of 6mg
|
Part A: Dose Level 2 (FE Study)
Part A: Oral vodobatinib (K0706) capsules of 24mg
|
Part B: Dose Level 1 (ESC)
Part B: Oral vodobatinib (K0706) capsules in once daily 12mg
|
Part B: Dose Level 2 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 24mg
|
Part B: Dose Level 3 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 48mg
|
Part B: Dose Level 4 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 66mg
|
Part B: Dose Level 5 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 90mg
|
Part B: Dose Level 6 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 126mg
|
Part B: Dose Level 7 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 174mg
|
Part B: Dose Level 8 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 204mg
|
Part B: Dose Level 9 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 240mg
|
Part B: Dose Level 1 (EXP)
Part B: Oral vodobatinib (K0706) capsules once daily 174 mg
|
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules at 90mg once daily. Includes a patient with CML-CP
|
Part C: Dose Level 2 (CML-AP)
Part C: Oral vodobatinib (K0706) capsules at 174mg, once daily. Includes patients with CML-AP
|
Part C: Dose Level 2 (CML-CP)
Part C: Oral vodobatinib (K0706) capsules at 174mg, once daily. Includes patients with CML-CP
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A
STARTED
|
6
|
6
|
6
|
6
|
8
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A
COMPLETED
|
5
|
6
|
6
|
6
|
8
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
6
|
7
|
3
|
7
|
15
|
6
|
3
|
12
|
0
|
0
|
0
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
2
|
3
|
9
|
4
|
2
|
8
|
0
|
0
|
0
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
7
|
1
|
4
|
6
|
2
|
1
|
4
|
0
|
0
|
0
|
|
Part C
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
5
|
17
|
|
Part C
CML-CP
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
17
|
|
Part C
CML-AP
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
|
Part C
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
9
|
|
Part C
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
8
|
Reasons for withdrawal
| Measure |
Part A: Dose Level 1 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
|
Part A: Dose Level 2 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 12mg
|
Part A: Dose Level 3 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
|
Part A: Placebo (SAD Study)
Part A: Oral placebo capsules
|
Part A: Dose Level 1 (FE Study)
Part A: Oral vodobatinib (K0706) capsules of 6mg
|
Part A: Dose Level 2 (FE Study)
Part A: Oral vodobatinib (K0706) capsules of 24mg
|
Part B: Dose Level 1 (ESC)
Part B: Oral vodobatinib (K0706) capsules in once daily 12mg
|
Part B: Dose Level 2 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 24mg
|
Part B: Dose Level 3 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 48mg
|
Part B: Dose Level 4 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 66mg
|
Part B: Dose Level 5 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 90mg
|
Part B: Dose Level 6 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 126mg
|
Part B: Dose Level 7 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 174mg
|
Part B: Dose Level 8 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 204mg
|
Part B: Dose Level 9 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 240mg
|
Part B: Dose Level 1 (EXP)
Part B: Oral vodobatinib (K0706) capsules once daily 174 mg
|
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules at 90mg once daily. Includes a patient with CML-CP
|
Part C: Dose Level 2 (CML-AP)
Part C: Oral vodobatinib (K0706) capsules at 174mg, once daily. Includes patients with CML-AP
|
Part C: Dose Level 2 (CML-CP)
Part C: Oral vodobatinib (K0706) capsules at 174mg, once daily. Includes patients with CML-CP
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
2
|
2
|
1
|
0
|
2
|
0
|
0
|
0
|
|
Part B
Progression of disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
5
|
1
|
2
|
2
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Part B
Missing
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Transitioning to alternate therapy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Consent withdrawal; trial terminated due to lack off compliance
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Increased worsening of memory impairment grade 2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part C
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
|
Part C
Progression of disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
|
Part C
Subject change treatment plan
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part C
Patient chose to come off trial being uncomfortable with long waiting period for drug hold
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
Baseline characteristics by cohort
| Measure |
Part A: Dose Level 1 (FE Study)
n=8 Participants
Part A: Oral vodobatinib (K0706) capsules 6mg
|
Part A: Dose Level 2 (FE Study)
n=8 Participants
Part A: Oral vodobatinib (K0706) capsules 24mg
|
Part B: Dose Level 1 (ESC)
n=1 Participants
Part B: Oral vodobatinib (K0706) capsules once daily 12mg
|
Part B: Dose Level 2 (ESC)
n=1 Participants
Part B: Oral vodobatinib (K0706) capsules once daily 24mg
|
Part B: Dose Level 3 (ESC)
n=6 Participants
Part B: Oral vodobatinib (K0706) capsules once daily 48mg
|
Part B: Dose Level 4 (ESC)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules once daily 66mg
|
Part B: Dose Level 5 (ESC)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules once daily 90mg
|
Part B: Dose Level 6 (ESC)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules once daily 126mg
|
Part B: Dose Level 7 (ESC)
n=15 Participants
Part B: Oral vodobatinib (K0706) capsules once daily 174mg
|
Part B: Dose Level 8 (ESC)
n=6 Participants
Part B: Oral vodobatinib (K0706) capsules once daily 204mg
|
Part B: Dose Level 9 (ESC)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules once daily 240mg
|
Part B: Dose Level 1 (EXP)
n=12 Participants
Part B: Oral vodobatinib (K0706) capsules once daily 174mg
|
Part C: Dose Level 1
n=1 Participants
Part C: Oral vodobatinib (K0706) capsules at 90mg once daily
|
Part C: Dose Level 2 (CML-AP)
n=5 Participants
Part C: Oral vodobatinib (K0706) capsules at 174mg, once daily.
|
Part C: Dose Level 2 (CML-CP)
n=17 Participants
Part C: Oral vodobatinib (K0706) capsules at 174mg, once daily.
|
Total
n=124 Participants
Total of all reporting groups
|
Part A: Dose Level 1 (SAD)
n=6 Participants
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
|
Part A: Dose Level 2 (SAD)
n=6 Participants
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 12mg
|
Part A: Dose Level 3 (SAD)
n=6 Participants
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
|
Part A: Placebo (SAD)
n=6 Participants
Part A: Oral placebo capsules once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Region of Enrollment
South Korea
|
0 participants
n=97 Participants
|
0 participants
n=488 Participants
|
0 participants
n=7 Participants
|
0 participants
n=9 Participants
|
1 participants
n=64 Participants
|
4 participants
n=10 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
9 participants
n=52 Participants
|
1 participants
n=55 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=55 Participants
|
0 participants
n=55 Participants
|
0 participants
n=56 Participants
|
15 participants
n=37 Participants
|
0 participants
n=1512 Participants
|
0 participants
n=504 Participants
|
0 participants
n=2016 Participants
|
0 participants
n=99 Participants
|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Age, Categorical
Age · Between 18 and 65 years
|
8 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
8 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
5 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
5 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
10 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
11 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
4 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
11 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
98 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Age, Categorical
Age · >=65 years
|
0 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
4 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
5 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
26 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Sex: Female, Male
Sex: Female, Male · Female
|
0 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
4 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
7 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
4 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
4 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
10 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
38 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Sex: Female, Male
Sex: Female, Male · Male
|
8 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
8 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
5 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
8 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
8 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
4 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
7 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
86 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Ethnicity (NIH/OMB)
Ethnicity · Hispanic or Latino
|
0 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Ethnicity (NIH/OMB)
Ethnicity · Not Hispanic or Latino
|
8 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
8 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
5 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
12 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
9 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
4 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
12 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
102 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
5 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
6 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
5 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Ethnicity (NIH/OMB)
Ethnicity · Unknown or Not Reported
|
0 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
5 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
19 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Race (NIH/OMB)
Race · Asian
|
0 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
4 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
9 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
12 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
36 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Race (NIH/OMB)
Race · Black or African American
|
0 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
13 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Race (NIH/OMB)
Race · White
|
7 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
5 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
4 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
12 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
55 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
5 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Race (NIH/OMB)
Race · More than one race
|
0 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
1 Participants
n=97 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=488 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=7 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=9 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=64 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=10 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
2 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
3 Participants
n=52 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=53 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=55 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
5 Participants
n=56 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
19 Participants
n=37 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=1512 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=504 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
1 Participants
n=2016 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
0 Participants
n=99 Participants • This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
|
|
Region of Enrollment
Romania
|
0 participants
n=97 Participants
|
0 participants
n=488 Participants
|
0 participants
n=7 Participants
|
0 participants
n=9 Participants
|
0 participants
n=64 Participants
|
0 participants
n=10 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=52 Participants
|
0 participants
n=55 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=55 Participants
|
2 participants
n=55 Participants
|
3 participants
n=56 Participants
|
5 participants
n=37 Participants
|
0 participants
n=1512 Participants
|
0 participants
n=504 Participants
|
0 participants
n=2016 Participants
|
0 participants
n=99 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=97 Participants
|
0 participants
n=488 Participants
|
0 participants
n=7 Participants
|
0 participants
n=9 Participants
|
2 participants
n=64 Participants
|
0 participants
n=10 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=52 Participants
|
0 participants
n=55 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=55 Participants
|
0 participants
n=55 Participants
|
0 participants
n=56 Participants
|
2 participants
n=37 Participants
|
0 participants
n=1512 Participants
|
0 participants
n=504 Participants
|
0 participants
n=2016 Participants
|
0 participants
n=99 Participants
|
|
Region of Enrollment
Hungary
|
0 participants
n=97 Participants
|
0 participants
n=488 Participants
|
0 participants
n=7 Participants
|
0 participants
n=9 Participants
|
0 participants
n=64 Participants
|
0 participants
n=10 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=52 Participants
|
0 participants
n=55 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=55 Participants
|
1 participants
n=55 Participants
|
1 participants
n=56 Participants
|
2 participants
n=37 Participants
|
0 participants
n=1512 Participants
|
0 participants
n=504 Participants
|
0 participants
n=2016 Participants
|
0 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=97 Participants
|
8 participants
n=488 Participants
|
0 participants
n=7 Participants
|
0 participants
n=9 Participants
|
0 participants
n=64 Participants
|
2 participants
n=10 Participants
|
1 participants
n=55 Participants
|
2 participants
n=53 Participants
|
1 participants
n=52 Participants
|
2 participants
n=55 Participants
|
2 participants
n=55 Participants
|
0 participants
n=53 Participants
|
1 participants
n=55 Participants
|
0 participants
n=55 Participants
|
3 participants
n=56 Participants
|
54 participants
n=37 Participants
|
6 participants
n=1512 Participants
|
6 participants
n=504 Participants
|
6 participants
n=2016 Participants
|
6 participants
n=99 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=97 Participants
|
0 participants
n=488 Participants
|
0 participants
n=7 Participants
|
0 participants
n=9 Participants
|
0 participants
n=64 Participants
|
0 participants
n=10 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
2 participants
n=52 Participants
|
0 participants
n=55 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=55 Participants
|
0 participants
n=55 Participants
|
1 participants
n=56 Participants
|
3 participants
n=37 Participants
|
0 participants
n=1512 Participants
|
0 participants
n=504 Participants
|
0 participants
n=2016 Participants
|
0 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=97 Participants
|
0 participants
n=488 Participants
|
0 participants
n=7 Participants
|
0 participants
n=9 Participants
|
0 participants
n=64 Participants
|
0 participants
n=10 Participants
|
1 participants
n=55 Participants
|
1 participants
n=53 Participants
|
0 participants
n=52 Participants
|
1 participants
n=55 Participants
|
1 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=55 Participants
|
0 participants
n=55 Participants
|
2 participants
n=56 Participants
|
6 participants
n=37 Participants
|
0 participants
n=1512 Participants
|
0 participants
n=504 Participants
|
0 participants
n=2016 Participants
|
0 participants
n=99 Participants
|
|
Region of Enrollment
France
|
0 participants
n=97 Participants
|
0 participants
n=488 Participants
|
0 participants
n=7 Participants
|
0 participants
n=9 Participants
|
1 participants
n=64 Participants
|
1 participants
n=10 Participants
|
1 participants
n=55 Participants
|
2 participants
n=53 Participants
|
3 participants
n=52 Participants
|
0 participants
n=55 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=55 Participants
|
1 participants
n=55 Participants
|
4 participants
n=56 Participants
|
13 participants
n=37 Participants
|
0 participants
n=1512 Participants
|
0 participants
n=504 Participants
|
0 participants
n=2016 Participants
|
0 participants
n=99 Participants
|
|
Region of Enrollment
India
|
0 participants
n=97 Participants
|
0 participants
n=488 Participants
|
1 participants
n=7 Participants
|
1 participants
n=9 Participants
|
2 participants
n=64 Participants
|
0 participants
n=10 Participants
|
0 participants
n=55 Participants
|
2 participants
n=53 Participants
|
0 participants
n=52 Participants
|
2 participants
n=55 Participants
|
0 participants
n=55 Participants
|
12 participants
n=53 Participants
|
0 participants
n=55 Participants
|
0 participants
n=55 Participants
|
0 participants
n=56 Participants
|
20 participants
n=37 Participants
|
0 participants
n=1512 Participants
|
0 participants
n=504 Participants
|
0 participants
n=2016 Participants
|
0 participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
0 participants
n=97 Participants
|
0 participants
n=488 Participants
|
0 participants
n=7 Participants
|
0 participants
n=9 Participants
|
0 participants
n=64 Participants
|
0 participants
n=10 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=52 Participants
|
0 participants
n=55 Participants
|
0 participants
n=55 Participants
|
0 participants
n=53 Participants
|
0 participants
n=55 Participants
|
1 participants
n=55 Participants
|
3 participants
n=56 Participants
|
4 participants
n=37 Participants
|
0 participants
n=1512 Participants
|
0 participants
n=504 Participants
|
0 participants
n=2016 Participants
|
0 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Approximately 56 ± 2 daysPopulation: Safety Analysis Set
Number of Participants with Adverse Events in Part A
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
n=6 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
n=8 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
n=8 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Examination of the Safety and Tolerability of Single Oral Doses of K0706
|
2 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Dose Limiting toxicities observed over a 4 week periodPopulation: Safety Analysis Set
PART B
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
n=15 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
n=6 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
n=12 Participants
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
To Determine the Maximum Tolerated Dose (MTD) as Determined by Frequency of Dose Limiting Toxicities
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)Population: Safety Analysis Set
Number of Participants with treatment emergent Adverse Events in Part B
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
n=15 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
n=6 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
n=12 Participants
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence and Severity of Treatment Emergent AEs (PART B)
|
7 Participants
|
2 Participants
|
7 Participants
|
13 Participants
|
6 Participants
|
3 Participants
|
10 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)Population: Efficacy Analysis Set
PART C: Proportion of subjects achieving Major Cytogenetic Response \[ defined as complete cytogenetic response (CCyR; 0% Ph+metaphases) or partial cytogenetic response (PCyR; 1-35% Ph+ metaphases)\] as assessed by conventional Karyotyping of Bone marrow aspirate
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=17 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
For CML Subjects in CP at Study Entry
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
13 Participants
|
—
|
PRIMARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)Population: Efficacy Analysis Set
PART C: Proportion of subjects achieving Major Hematologic Response \[ defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)\] as assessed by complete blood count of peripheral blood sample
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=5 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
For CML Subjects in AP at Study Entry
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)Population: No participants with CML-BP were enrolled; therefore, the number of participants recruited and analyzed is reported as zero.
PART C: Proportion of subjects achieving Major Hematologic Response \[defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)\] as assessed by complete blood count of peripheral blood sample
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 28 ± 2 daysPopulation: Pharmacokinetic Analysis Set
Part A
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
To Characterize the Pharmacokinetics (Cmax) of K0706 After Single Oral Doses in Healthy Male Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
220.2 ng/mL
Geometric Coefficient of Variation 41.1
|
275.6 ng/mL
Geometric Coefficient of Variation 28.1
|
866.5 ng/mL
Geometric Coefficient of Variation 35.9
|
SECONDARY outcome
Timeframe: Approximately 28 ± 2 daysPopulation: Pharmacokinetic Analysis Set
Part A
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=8 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=8 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
To Characterize the Pharmacokinetics of K0706 (Cmax) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
Cmax: FE study (Fasted)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
121.4 ng/mL
Geometric Coefficient of Variation 25.8
|
642 ng/mL
Geometric Coefficient of Variation 54.6
|
—
|
|
To Characterize the Pharmacokinetics of K0706 (Cmax) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
Cmax: FE study (Fed)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
67.76 ng/mL
Geometric Coefficient of Variation 53.7
|
323.7 ng/mL
Geometric Coefficient of Variation 26.3
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)Population: PK Analysis Set
PART B
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
n=15 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
n=6 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
n=12 Participants
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Profile of K0706 - Cmax [The Maximum (Peak) Observed Drug Concentration After Dose Administration]
|
623.0 ng/mL
Geometric Coefficient of Variation 65.9
|
2457.4 ng/mL
Geometric Coefficient of Variation 84.9
|
3174.9 ng/mL
Geometric Coefficient of Variation 89.1
|
3308.6 ng/mL
Geometric Coefficient of Variation 108.0
|
2921.9 ng/mL
Geometric Coefficient of Variation 58.4
|
4634. ng/mL
Geometric Coefficient of Variation 108.0
|
2961.4 ng/mL
Geometric Coefficient of Variation 61.8
|
685.0 ng/mL
|
589.0 ng/mL
|
964.8 ng/mL
Geometric Coefficient of Variation 63.1
|
SECONDARY outcome
Timeframe: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)Population: PK Analysis Set
PART B
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
n=15 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
n=6 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
n=12 Participants
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Profile of Vodobatinib (K0706) - Tmax [The Time to Reach Maximum (Peak) Drug Concentration After Dose Administration]
|
4 hours
Interval 2.0 to 5.7
|
2 hours
Interval 1.0 to 24.1
|
2.6 hours
Interval 2.0 to 8.0
|
2 hours
Interval 1.9 to 4.0
|
2.3 hours
Interval 2.0 to 4.0
|
2.5 hours
Interval 2.0 to 8.0
|
2.1 hours
Interval 0.0 to 8.0
|
1 hours
Interval 1.0 to 1.0
|
2 hours
Interval 2.0 to 2.0
|
2.5 hours
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)Population: PK Analysis Set
PART B
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
n=7 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
n=15 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
n=6 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
n=3 Participants
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
n=12 Participants
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Profile of Vodobatinib (K0706) - AUC[0-tau] (AUC Over the Dosing Interval of 0-24 Hours).
|
4161.2 h*ng/mL
Geometric Coefficient of Variation 76.2
|
22019.8 h*ng/mL
Geometric Coefficient of Variation 9.4
|
18676.9 h*ng/mL
Geometric Coefficient of Variation 97.6
|
23898.3 h*ng/mL
Geometric Coefficient of Variation 108.4
|
25276.5 h*ng/mL
Geometric Coefficient of Variation 61.1
|
23871.6 h*ng/mL
Geometric Coefficient of Variation 14.7
|
25323.9 h*ng/mL
Geometric Coefficient of Variation 61.9
|
3280.4 h*ng/mL
|
5024.2 h*ng/mL
|
8369.7 h*ng/mL
Geometric Coefficient of Variation 149.4
|
SECONDARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)Population: Efficacy Analysis Set
PART C
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=17 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
In Subjects With CML- CP:Proportion of Subjects Achieving Complete Hematological Response as Assessed by Complete Blood Count of Peripheral Blood Sample
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)Population: Efficacy Analysis Set
PART C
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=17 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
In Subjects With CML- CP:Proportion of Subjects Achieving Complete Cytogenetic Response as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)Population: Efficacy Analysis Set
PART C
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=17 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
In Subjects With CML- CP:Proportion of Subjects Achieving Major Molecular Response as Assessed by BCR-ABL Transcript Levels (BCR-ABL1 Ratio of ≤ 0.1%) in Peripheral Blood Using PCR (Polymerase Chain Reaction)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)Population: Efficacy Analysis Set
PART C
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=5 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Complete Cytogenetic Response as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of K0706Population: Efficacy Analysis Set
Part C
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=5 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Partial Cytogenetic Response (PCyR) as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)Population: Efficacy Analysis Set
PART C
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=5 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Major Molecular Response as Assessed by BCR-ABL Transcript Levels (BCR-ABL1 Ratio of ≤ 0.1%) in Peripheral Blood Using PCR (Polymerase Chain Reaction)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)Population: Efficacy Analysis Set (Cycle 2; Time to MCyR differs from the proportion achieving MCyR because it is a time-to-event endpoint calculated only for subjects who achieved MCyR, whereas the proportion endpoint includes all evaluable subjects and reflects whether MCyR was achieved at any time.)
PART C; Time to response was calculated as time from date of first dose to date of first occurrence of best response
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=5 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Major Cytogenetic Response (MCyR): Time to MCyR is the Time From First Dose to First MCyR (0-35% Ph+ Metaphases); Computed Only for CML-CP Subjects Who Achieved MCyR
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.9 months
Standard Error 2.53
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)Population: Efficacy Analysis Set
PART C; Time to response was calculated as time from date of first dose to date of first occurrence of best response
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=7 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Major Molecular Response : Time to MMR is the Time From First Dose to First MMR (BCR-ABL1 Ratio of ≤ 0.1%) Computed Only for CML-CP Subjects Who Achieved MMR
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.0 months
Standard Deviation 4.71
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.Population: Safety Analysis Set
PART C
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=22 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
In All Subjects Progression Free Survival (PFS)
At 12 months
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
80.6 percentage of participants
Interval 56.1 to 92.3
|
—
|
|
In All Subjects Progression Free Survival (PFS)
At 24 months
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
64.5 percentage of participants
Interval 35.6 to 83.0
|
—
|
|
In All Subjects Progression Free Survival (PFS)
At 36 months
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
55.3 percentage of participants
Interval 26.3 to 76.9
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.Population: Safety Analysis Set
PART C
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=22 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
In All Subjects Overall Survival (OS)
At 12 months
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
95.5 percentage of participants
Interval 71.9 to 99.3
|
—
|
|
In All Subjects Overall Survival (OS)
At 24 months
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
95.5 percentage of participants
Interval 71.9 to 99.3
|
—
|
|
In All Subjects Overall Survival (OS)
At 36 months
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
83.5 percentage of participants
Interval 43.2 to 96.2
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.Population: Safety Analysis Set
Number of Participants with treatment emergent Adverse Events in Part C
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=1 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=22 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence and Severity of Treatment Emergent AEs (PART C)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)Population: PK Analysis Set; No pharmacokinetic data were collected for the 90mg cohort because the subject did not attend the scheduled visit, and therefore pharmacokinetic blood samples were not obtained.
PART C
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=21 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Profile of K0706 - Cmax [The Maximum (Peak) Observed Drug Concentration After Dose Administration]
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3318.8 ng/mL
Geometric Coefficient of Variation 78
|
—
|
SECONDARY outcome
Timeframe: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)Population: PK Analysis Set; No pharmacokinetic data were collected for the 90mg cohort because the subject did not attend the scheduled visit, and therefore pharmacokinetic blood samples were not obtained.
PART C
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=21 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Profile of Vodobatinib (K0706) - Tmax [The Time to Reach Maximum (Peak) Drug Concentration After Dose Administration]
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 hours
Interval 0.0 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Approximately 28 ± 2 daysPopulation: Pharmacokinetic Analysis Set
Part A
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
n=6 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
To Characterize the Pharmacokinetics (AUC(0-inf)) of K0706 After Single Oral Doses in Healthy Male Subjects
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1618 ng*h/mL
Geometric Coefficient of Variation 41.7
|
2419 ng*h/mL
Geometric Coefficient of Variation 67.5
|
6322 ng*h/mL
Geometric Coefficient of Variation 32.6
|
SECONDARY outcome
Timeframe: Approximately 28 ± 2 daysPopulation: Pharmacokinetic Analysis Set
Part A
Outcome measures
| Measure |
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
|
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 90mg, once daily
|
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 126mg, once daily
|
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 174mg, once daily
|
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 204mg, once daily
|
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 240mg, once daily
|
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules of 174mg, once daily
|
Part B: Dose Level 1 (ESC Study)
n=8 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
|
Part B: Dose Level 2 (ESC Study)
n=8 Participants
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
|
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|
|
To Characterize the Pharmacokinetics of K0706 (AUC(0-inf)) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
AUC(0-inf): FE study (Fed)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
971.8 ng*h/mL
Geometric Coefficient of Variation 24.2
|
4521 ng*h/mL
Geometric Coefficient of Variation 28.8
|
—
|
|
To Characterize the Pharmacokinetics of K0706 (AUC(0-inf)) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
AUC(0-inf): FE study (Fasted)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1093 ng*h/mL
Geometric Coefficient of Variation 31.4
|
5739 ng*h/mL
Geometric Coefficient of Variation 26.2
|
—
|
Adverse Events
Part A: Dose Level 1 (SAD Study)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: Dose Level 2 (SAD Study)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Dose Level 3 (SAD Study)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Placebo (SAD Study)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Dose Level 1 (FE Study)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A: Dose Level 2 (FE Study)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: Dose Level 1 (ESC Study)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Dose Level 2 (ESC Study)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Dose Level 3 (ESC Study)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Part B: Dose Level 4 (ESC Study)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Part B: Dose Level 5 (ESC Study)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: Dose Level 6 (ESC Study)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Part B: Dose Level 7 (ESC Study)
Serious events: 3 serious events
Other events: 13 other events
Deaths: 1 deaths
Part B: Dose Level 8 (ESC Study)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Part B: Dose Level 9 (ESC Study)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B: Dose Level 1 (EXP Study)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 1 deaths
Part C: Dose Level 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part C: Dose Level 2
Serious events: 6 serious events
Other events: 20 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part A: Dose Level 1 (SAD Study)
n=6 participants at risk
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
|
Part A: Dose Level 2 (SAD Study)
n=6 participants at risk
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 12mg
|
Part A: Dose Level 3 (SAD Study)
n=6 participants at risk
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
|
Part A: Placebo (SAD Study)
n=6 participants at risk
Part A: Oral placebo capsules
|
Part A: Dose Level 1 (FE Study)
n=8 participants at risk
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
|
Part A: Dose Level 2 (FE Study)
n=8 participants at risk
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
|
Part B: Dose Level 1 (ESC Study)
n=1 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 12mg
|
Part B: Dose Level 2 (ESC Study)
n=1 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 24mg
|
Part B: Dose Level 3 (ESC Study)
n=6 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 48mg
|
Part B: Dose Level 4 (ESC Study)
n=7 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 66mg
|
Part B: Dose Level 5 (ESC Study)
n=3 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 90mg
|
Part B: Dose Level 6 (ESC Study)
n=7 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 126mg
|
Part B: Dose Level 7 (ESC Study)
n=15 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 174mg
|
Part B: Dose Level 8 (ESC Study)
n=6 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 204mg
|
Part B: Dose Level 9 (ESC Study)
n=3 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 240mg
|
Part B: Dose Level 1 (EXP Study)
n=12 participants at risk
Part B: Oral vodobatinib (K0706) capsules at 174 mg once daily
|
Part C: Dose Level 1
n=1 participants at risk
Part C: Oral vodobatinib (K0706) capsules at 90mg once daily
|
Part C: Dose Level 2
n=22 participants at risk
Part C: Oral vodobatinib (K0706) capsules 174mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Dementia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Disease progression
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Sudden death
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Vascular disorders
Septic shock
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Immune system disorders
Swollen tongue
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
Other adverse events
| Measure |
Part A: Dose Level 1 (SAD Study)
n=6 participants at risk
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
|
Part A: Dose Level 2 (SAD Study)
n=6 participants at risk
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 12mg
|
Part A: Dose Level 3 (SAD Study)
n=6 participants at risk
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
|
Part A: Placebo (SAD Study)
n=6 participants at risk
Part A: Oral placebo capsules
|
Part A: Dose Level 1 (FE Study)
n=8 participants at risk
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
|
Part A: Dose Level 2 (FE Study)
n=8 participants at risk
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
|
Part B: Dose Level 1 (ESC Study)
n=1 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 12mg
|
Part B: Dose Level 2 (ESC Study)
n=1 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 24mg
|
Part B: Dose Level 3 (ESC Study)
n=6 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 48mg
|
Part B: Dose Level 4 (ESC Study)
n=7 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 66mg
|
Part B: Dose Level 5 (ESC Study)
n=3 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 90mg
|
Part B: Dose Level 6 (ESC Study)
n=7 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 126mg
|
Part B: Dose Level 7 (ESC Study)
n=15 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 174mg
|
Part B: Dose Level 8 (ESC Study)
n=6 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 204mg
|
Part B: Dose Level 9 (ESC Study)
n=3 participants at risk
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 240mg
|
Part B: Dose Level 1 (EXP Study)
n=12 participants at risk
Part B: Oral vodobatinib (K0706) capsules at 174 mg once daily
|
Part C: Dose Level 1
n=1 participants at risk
Part C: Oral vodobatinib (K0706) capsules at 90mg once daily
|
Part C: Dose Level 2
n=22 participants at risk
Part C: Oral vodobatinib (K0706) capsules 174mg, once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
50.0%
3/6 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
18.2%
4/22 • Number of events 4 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
12.5%
1/8 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
25.0%
3/12 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
2/3 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
18.2%
4/22 • Number of events 4 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
2/3 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
12.5%
1/8 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
12.5%
1/8 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
12.5%
1/8 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
2/3 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Fungal foot infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Human polyomavirus infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
2/3 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
3/3 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
2/12 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
18.2%
4/22 • Number of events 4 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
25.0%
3/12 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.6%
3/22 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
50.0%
3/6 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
22.7%
5/22 • Number of events 5 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
2/12 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
50.0%
3/6 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
2/3 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
50.0%
3/6 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
4/12 • Number of events 4 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
12.5%
1/8 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
2/12 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Intestinal atony
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
50.0%
3/6 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
42.9%
3/7 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
2/3 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
57.1%
4/7 • Number of events 4 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
58.3%
7/12 • Number of events 7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
22.7%
5/22 • Number of events 5 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
42.9%
3/7 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
20.0%
3/15 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.6%
3/22 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
42.9%
3/7 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.6%
3/22 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
25.0%
3/12 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.6%
3/22 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
2/3 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
2/12 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
2/3 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
2/3 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
20.0%
3/15 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
18.2%
4/22 • Number of events 4 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
57.1%
4/7 • Number of events 4 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.6%
3/22 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
2/3 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Disease progression
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Swelling face
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Cyst
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Face oedema
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Generalised oedema
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
General disorders
Sudden death
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
20.0%
3/15 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
25.0%
3/12 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Amylase increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Weight increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Intestinal transit time decreased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Investigations
Troponin I increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
42.9%
3/7 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.6%
3/22 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Tetany
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
26.7%
4/15 • Number of events 4 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
27.3%
6/22 • Number of events 6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.6%
3/22 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
12.5%
1/8 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
4/6 • Number of events 4 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
66.7%
2/3 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
2/12 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.6%
3/22 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Vertigo
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Dementia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
50.0%
3/6 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
2/12 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
18.2%
4/22 • Number of events 4 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
3/3 • Number of events 3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
18.2%
4/22 • Number of events 4 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
13.3%
2/15 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
9.1%
2/22 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
2/6 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
12.5%
1/8 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord thickening
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
28.6%
2/7 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
2/12 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
22.7%
5/22 • Number of events 5 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
2/12 • Number of events 2 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Psychiatric disorders
Polydipsia psychogenic
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
100.0%
1/1 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Eye disorders
Miosis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
8.3%
1/12 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
4.5%
1/22 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
14.3%
1/7 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
6.7%
1/15 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
33.3%
1/3 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
16.7%
1/6 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
12.5%
1/8 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
12.5%
1/8 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
|
Infections and infestations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/8 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
12.5%
1/8 • Number of events 1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/7 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/15 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/6 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/3 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/12 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/1 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
0.00%
0/22 • Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
|
Additional Information
Head, Product Development
Sun Pharma Advanced Research Company Limited
Phone: 912266455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60