Trial Outcomes & Findings for A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer (NCT NCT04505826)
NCT ID: NCT04505826
Last Updated: 2026-05-11
Results Overview
Number of Participants with Dose Limiting Toxicities (DLT) during Dose Escalation Only
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
153 participants
Primary outcome timeframe
Up to 28 days from start of treatment
Results posted on
2026-05-11
Participant Flow
Participant milestones
| Measure |
150 mg QD (Phase 1a)
Patients dosed at 150mg QD with OP-1250 in Phase 1a
|
210 mg QD (Phase 1a)
Patients dosed at 210mg QD with OP-1250 in Phase 1a
|
300 mg QD (Phase 1a)
Patients dosed at 300mg QD with OP-1250 in Phase 1a
|
120 mg QD (Phase 2COHORT C ONLY)
Patients dosed at 120mg QD with OP-1250 in Phase 2 cohort C only
|
120 mg QD (Phase 1a)
Patients dosed at 120mg QD with OP-1250 in Phase 1a
|
120 mg QD (Phase 1b)
Patients dosed at 120mg QD with OP-1250 in Phase 1b
|
120 mg QD (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2
|
30 mg QD (Phase 1a)
Patients dosed at 30mg QD with OP-1250 in Phase 1a
|
60 mg QD (Phase 1a)
Patients dosed at 60mg QD with OP-1250 in Phase 1a
|
60 mg (Phase 1b)
Patients dosed at 60mg QD with OP-1250 in Phase 1b
|
90 mg QD (Phase 1a)
Patients dosed at 90mg QD with OP-1250 in Phase 1a
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
7
|
7
|
6
|
29
|
48
|
5
|
6
|
27
|
6
|
|
Overall Study
COMPLETED
|
5
|
7
|
7
|
7
|
6
|
29
|
46
|
5
|
6
|
26
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
150 mg QD (Phase 1a)
Patients dosed at 150mg QD with OP-1250 in Phase 1a
|
210 mg QD (Phase 1a)
Patients dosed at 210mg QD with OP-1250 in Phase 1a
|
300 mg QD (Phase 1a)
Patients dosed at 300mg QD with OP-1250 in Phase 1a
|
120 mg QD (Phase 2COHORT C ONLY)
Patients dosed at 120mg QD with OP-1250 in Phase 2 cohort C only
|
120 mg QD (Phase 1a)
Patients dosed at 120mg QD with OP-1250 in Phase 1a
|
120 mg QD (Phase 1b)
Patients dosed at 120mg QD with OP-1250 in Phase 1b
|
120 mg QD (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2
|
30 mg QD (Phase 1a)
Patients dosed at 30mg QD with OP-1250 in Phase 1a
|
60 mg QD (Phase 1a)
Patients dosed at 60mg QD with OP-1250 in Phase 1a
|
60 mg (Phase 1b)
Patients dosed at 60mg QD with OP-1250 in Phase 1b
|
90 mg QD (Phase 1a)
Patients dosed at 90mg QD with OP-1250 in Phase 1a
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Patient remained on study treatment in an extension of the protocol
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
Baseline characteristics by cohort
| Measure |
30 mg QD (Phase 1a)
n=5 Participants
Patients dosed at 30mg QD with OP-1250 in Phase 1a
|
60 mg QD (Phase 1a)
n=6 Participants
Patients dosed at 60mg QD with OP-1250 in Phase 1a
|
60 mg (Phase 1b)
n=27 Participants
Patients dosed at 60mg QD with OP-1250 in Phase 1b
|
90 mg QD (Phase 1a)
n=6 Participants
Patients dosed at 90mg QD with OP-1250 in Phase 1a
|
120 mg QD (Phase 1a)
n=6 Participants
Patients dosed at 120mg QD with OP-1250 in Phase 1a
|
120 mg QD (Phase 1b)
n=29 Participants
Patients dosed at 120mg QD with OP-1250 in Phase 1b
|
120 mg QD (Phase 2)
n=48 Participants
Patients dosed at 120mg QD with OP-1250 in Phase 2 (cohort A and B only)
|
150 mg QD (Phase 1a)
n=5 Participants
Patients dosed at 150mg QD with OP-1250 in Phase 1a
|
210 mg QD (Phase 1a)
n=7 Participants
Patients dosed at 210 QD with OP-1250 in Phase 1a
|
300 mg QD (Phase 1a)
n=7 Participants
Patients dosed at 300mg QD with OP-1250 in Phase 1a
|
120 mg QD (Phase 2 COHORT C ONLY)
n=7 Participants
Patients dosed at 120mg QD with OP-1250 in Phase 2 (cohort C only)
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=295 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=153 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=44 Participants
|
3 Participants
n=10 Participants
|
18 Participants
n=30 Participants
|
6 Participants
n=1054 Participants
|
4 Participants
n=97 Participants
|
17 Participants
n=488 Participants
|
33 Participants
n=825 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=295 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=7 Participants
|
99 Participants
n=153 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=44 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
2 Participants
n=97 Participants
|
12 Participants
n=488 Participants
|
15 Participants
n=825 Participants
|
4 Participants
n=40 Participants
|
4 Participants
n=295 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=7 Participants
|
54 Participants
n=153 Participants
|
|
Age, Continuous
|
63 years
n=44 Participants
|
65 years
n=10 Participants
|
60 years
n=30 Participants
|
57 years
n=1054 Participants
|
62.5 years
n=97 Participants
|
61 years
n=488 Participants
|
62 years
n=825 Participants
|
76 years
n=40 Participants
|
65 years
n=295 Participants
|
64 years
n=27 Participants
|
49 years
n=7 Participants
|
61 years
n=153 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=44 Participants
|
6 Participants
n=10 Participants
|
27 Participants
n=30 Participants
|
6 Participants
n=1054 Participants
|
6 Participants
n=97 Participants
|
29 Participants
n=488 Participants
|
48 Participants
n=825 Participants
|
5 Participants
n=40 Participants
|
6 Participants
n=295 Participants
|
7 Participants
n=27 Participants
|
7 Participants
n=7 Participants
|
152 Participants
n=153 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=295 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=153 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=295 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
3 Participants
n=825 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=295 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=295 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
1 Participants
n=97 Participants
|
3 Participants
n=488 Participants
|
3 Participants
n=825 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=295 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=153 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=44 Participants
|
5 Participants
n=10 Participants
|
20 Participants
n=30 Participants
|
4 Participants
n=1054 Participants
|
5 Participants
n=97 Participants
|
24 Participants
n=488 Participants
|
39 Participants
n=825 Participants
|
5 Participants
n=40 Participants
|
7 Participants
n=295 Participants
|
6 Participants
n=27 Participants
|
7 Participants
n=7 Participants
|
127 Participants
n=153 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=488 Participants
|
0 Participants
n=825 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=295 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=153 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=44 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=30 Participants
|
2 Participants
n=1054 Participants
|
0 Participants
n=97 Participants
|
2 Participants
n=488 Participants
|
3 Participants
n=825 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=295 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=153 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=44 Participants
|
6 participants
n=10 Participants
|
20 participants
n=30 Participants
|
4 participants
n=1054 Participants
|
6 participants
n=97 Participants
|
23 participants
n=488 Participants
|
46 participants
n=825 Participants
|
5 participants
n=40 Participants
|
7 participants
n=295 Participants
|
7 participants
n=27 Participants
|
5 participants
n=7 Participants
|
134 participants
n=153 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=44 Participants
|
0 participants
n=10 Participants
|
7 participants
n=30 Participants
|
2 participants
n=1054 Participants
|
0 participants
n=97 Participants
|
6 participants
n=488 Participants
|
2 participants
n=825 Participants
|
0 participants
n=40 Participants
|
0 participants
n=295 Participants
|
0 participants
n=27 Participants
|
2 participants
n=7 Participants
|
19 participants
n=153 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days from start of treatmentPopulation: Per the protocol DLTs were evaluated at Escalation phase (1a) only
Number of Participants with Dose Limiting Toxicities (DLT) during Dose Escalation Only
Outcome measures
| Measure |
30 mg QD (Phase 1a)
n=5 Participants
Patients dosed at 30mg QD with OP-1250 in Phase 1a
|
60 mg QD (Phase 1a)
n=6 Participants
Patients dosed at 60mg QD with OP-1250 in Phase 1a
|
90 mg QD (Phase 1a)
n=6 Participants
Patients dosed at 90mg QD with OP-1250 in Phase 1a
|
120 mg QD (Phase 1a)
n=6 Participants
Patients dosed at 120mg QD with OP-1250 in Phase 1a
|
150 mg QD (Phase 1a)
n=5 Participants
Patients dosed at 150mg QD with OP-1250 in Phase 1a
|
210 mg QD (Phase 1a)
n=7 Participants
Patients dosed at 210mg QD with OP-1250 in Phase 1a
|
300 mg QD (Phase 1a)
n=7 Participants
Patients dosed at 300mg QD with OP-1250 in Phase 1a
|
TOTAL (Phase 1a)
n=42 Participants
Total Patients Dosed in Phase 1a
|
60 mg QD (Phase 1b)
Patients dosed at 60mg QD with OP-1250 in Phase 1b
|
120 mg QD (Phase1b)
Patients dosed at 120mg QD with OP-1250 in Phase 1b
|
Cohort A (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort A
|
Cohort B (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort B
|
Cohort C (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort C
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicities (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years, 11 months, and 17 days.Characterize the incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250 in patients that had at least one treatment emergent adverse event according to NCI-CTCAE version 5.0.
Outcome measures
| Measure |
30 mg QD (Phase 1a)
n=5 Participants
Patients dosed at 30mg QD with OP-1250 in Phase 1a
|
60 mg QD (Phase 1a)
n=33 Participants
Patients dosed at 60mg QD with OP-1250 in Phase 1a
|
90 mg QD (Phase 1a)
n=6 Participants
Patients dosed at 90mg QD with OP-1250 in Phase 1a
|
120 mg QD (Phase 1a)
n=83 Participants
Patients dosed at 120mg QD with OP-1250 in Phase 1a
|
150 mg QD (Phase 1a)
n=5 Participants
Patients dosed at 150mg QD with OP-1250 in Phase 1a
|
210 mg QD (Phase 1a)
n=7 Participants
Patients dosed at 210mg QD with OP-1250 in Phase 1a
|
300 mg QD (Phase 1a)
n=7 Participants
Patients dosed at 300mg QD with OP-1250 in Phase 1a
|
TOTAL (Phase 1a)
n=7 Participants
Total Patients Dosed in Phase 1a
|
60 mg QD (Phase 1b)
Patients dosed at 60mg QD with OP-1250 in Phase 1b
|
120 mg QD (Phase1b)
Patients dosed at 120mg QD with OP-1250 in Phase 1b
|
Cohort A (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort A
|
Cohort B (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort B
|
Cohort C (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort C
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Characterize the Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) of OP-1250 That Had at Least One Treatment Emergent Adverse Event
|
5 Participants
|
29 Participants
|
5 Participants
|
79 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: AUC (0-24) at steady state after 4 weeks of administrationPopulation: Includes AUC (ng·h/mL) at steady state for subjects treated across all dose levels.
Plasma concentrations of OP-1250 assessed steady state
Outcome measures
| Measure |
30 mg QD (Phase 1a)
n=5 Participants
Patients dosed at 30mg QD with OP-1250 in Phase 1a
|
60 mg QD (Phase 1a)
n=26 Participants
Patients dosed at 60mg QD with OP-1250 in Phase 1a
|
90 mg QD (Phase 1a)
n=6 Participants
Patients dosed at 90mg QD with OP-1250 in Phase 1a
|
120 mg QD (Phase 1a)
n=77 Participants
Patients dosed at 120mg QD with OP-1250 in Phase 1a
|
150 mg QD (Phase 1a)
n=2 Participants
Patients dosed at 150mg QD with OP-1250 in Phase 1a
|
210 mg QD (Phase 1a)
n=6 Participants
Patients dosed at 210mg QD with OP-1250 in Phase 1a
|
300 mg QD (Phase 1a)
n=6 Participants
Patients dosed at 300mg QD with OP-1250 in Phase 1a
|
TOTAL (Phase 1a)
Total Patients Dosed in Phase 1a
|
60 mg QD (Phase 1b)
Patients dosed at 60mg QD with OP-1250 in Phase 1b
|
120 mg QD (Phase1b)
Patients dosed at 120mg QD with OP-1250 in Phase 1b
|
Cohort A (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort A
|
Cohort B (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort B
|
Cohort C (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort C
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics of OP-1250
|
1956 ng/mL*h
Geometric Coefficient of Variation 33.0
|
4014 ng/mL*h
Geometric Coefficient of Variation 46.2
|
7668 ng/mL*h
Geometric Coefficient of Variation 82.4
|
9163 ng/mL*h
Geometric Coefficient of Variation 38.1
|
12580 ng/mL*h
Geometric Coefficient of Variation 27.3
|
22439 ng/mL*h
Geometric Coefficient of Variation 47.2
|
25438 ng/mL*h
Geometric Coefficient of Variation 40.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Imaging studies performed every 8 weeks from date of first dose through cycle 9 then afterwards every 12 weeks until date of first documented disease progression: assessed up to 3 years, 11 months, and 17 daysPopulation: Participants analyzed were evaluable for response which includes measurable disease. Overall response rate uses confirmed Partial Response (cPR)
Tumor response will be evaluated in patients with measurable or evaluable disease, using RECISTv1.1 guidelines (Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR)). Overall response rate which includes confirmed Partial Response (cPR).
Outcome measures
| Measure |
30 mg QD (Phase 1a)
n=5 Participants
Patients dosed at 30mg QD with OP-1250 in Phase 1a
|
60 mg QD (Phase 1a)
n=28 Participants
Patients dosed at 60mg QD with OP-1250 in Phase 1a
|
90 mg QD (Phase 1a)
n=4 Participants
Patients dosed at 90mg QD with OP-1250 in Phase 1a
|
120 mg QD (Phase 1a)
n=62 Participants
Patients dosed at 120mg QD with OP-1250 in Phase 1a
|
150 mg QD (Phase 1a)
n=1 Participants
Patients dosed at 150mg QD with OP-1250 in Phase 1a
|
210 mg QD (Phase 1a)
n=4 Participants
Patients dosed at 210mg QD with OP-1250 in Phase 1a
|
300 mg QD (Phase 1a)
n=4 Participants
Patients dosed at 300mg QD with OP-1250 in Phase 1a
|
TOTAL (Phase 1a)
n=5 Participants
Total Patients Dosed in Phase 1a
|
60 mg QD (Phase 1b)
Patients dosed at 60mg QD with OP-1250 in Phase 1b
|
120 mg QD (Phase1b)
Patients dosed at 120mg QD with OP-1250 in Phase 1b
|
Cohort A (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort A
|
Cohort B (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort B
|
Cohort C (Phase 2)
Patients dosed at 120mg QD with OP-1250 in Phase 2 Cohort C
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-tumor Activity of OP-1250 (cPR)
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
30 mg QD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
60 mg QD
Serious events: 4 serious events
Other events: 29 other events
Deaths: 5 deaths
90 mg QD
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
120 mg QD
Serious events: 16 serious events
Other events: 79 other events
Deaths: 5 deaths
150 mg QD
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
210 mg QD
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
300 mg QD
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
120 mg QD (COHORT C ONLY)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
30 mg QD
n=5 participants at risk
Patients dosed at 30mg QD with OP-1250
|
60 mg QD
n=33 participants at risk
Patients dosed at 60mg QD with OP-1250
|
90 mg QD
n=6 participants at risk
Patients dosed at 90mg QD with OP-1250
|
120 mg QD
n=83 participants at risk
Patients dosed at 120mg QD with OP-1250
|
150 mg QD
n=5 participants at risk
Patients dosed at 150mg QD with OP-1250
|
210 mg QD
n=7 participants at risk
Patients dosed at 210mg QD with OP-1250
|
300 mg QD
n=7 participants at risk
Patients dosed at 300mg QD with OP-1250
|
120 mg QD (COHORT C ONLY)
n=7 participants at risk
Patients dosed at 120mg QD with OP-1250 in cohort C only
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
3.0%
1/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
3.0%
1/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
3.0%
1/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
3.0%
1/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Device related infection
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
3.0%
1/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Skin infection
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
2.4%
2/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Vomiting
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
2.4%
2/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Abdominal pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Constipation
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
3.0%
1/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Haematemesis
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Large intestinal obstruction
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Small intestinal obstruction
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
2.4%
2/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Disease progression
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Fatigue
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
3.0%
1/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Pyrexia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
3.0%
1/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
1.2%
1/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
Other adverse events
| Measure |
30 mg QD
n=5 participants at risk
Patients dosed at 30mg QD with OP-1250
|
60 mg QD
n=33 participants at risk
Patients dosed at 60mg QD with OP-1250
|
90 mg QD
n=6 participants at risk
Patients dosed at 90mg QD with OP-1250
|
120 mg QD
n=83 participants at risk
Patients dosed at 120mg QD with OP-1250
|
150 mg QD
n=5 participants at risk
Patients dosed at 150mg QD with OP-1250
|
210 mg QD
n=7 participants at risk
Patients dosed at 210mg QD with OP-1250
|
300 mg QD
n=7 participants at risk
Patients dosed at 300mg QD with OP-1250
|
120 mg QD (COHORT C ONLY)
n=7 participants at risk
Patients dosed at 120mg QD with OP-1250 in cohort C only
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
42.4%
14/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
33.3%
2/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
66.3%
55/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
80.0%
4/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
57.1%
4/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
85.7%
6/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
42.9%
3/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
15.2%
5/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.9%
24/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
40.0%
2/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
71.4%
5/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
18.2%
6/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
19.3%
16/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
57.1%
4/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
42.9%
3/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
42.9%
3/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
18.2%
6/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.9%
14/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
7.2%
6/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
9.6%
8/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Fatigue
|
40.0%
2/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
39.4%
13/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.9%
24/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
57.1%
4/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Pyrexia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.0%
5/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Influenza like illness
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Non-cardiac chest pain
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Chills
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Asthenia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Localised oedema
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Oedema
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
General disorders
Catheter site pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
18.2%
6/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.5%
12/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
9.1%
3/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
10.8%
9/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
18.2%
6/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
7.2%
6/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
9.1%
3/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
21.2%
7/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
21.7%
18/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
57.1%
4/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
9.1%
3/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
8.4%
7/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.0%
5/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Ageusia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Anosmia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
19.3%
16/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
40.0%
2/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
13.3%
11/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
15.7%
13/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
7.2%
6/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Investigations
QRS axis abnormal
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
9.6%
8/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
9.1%
3/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
10.8%
9/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
8.4%
7/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
9.1%
3/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
15.7%
13/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
15.2%
5/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
8.4%
7/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
42.9%
3/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmalgia
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
8.4%
7/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
12.1%
4/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.0%
5/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Sinusitis
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
8.4%
7/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
42.9%
3/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
42.9%
3/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
42.9%
3/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
12.1%
4/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
8.4%
7/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
33.3%
2/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Psychiatric disorders
Irritability
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Psychiatric disorders
Libido decreased
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Eye disorders
Photopsia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
33.3%
2/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.0%
5/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
42.9%
3/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Eye disorders
Cataract
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Eye disorders
Diplopia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Eye disorders
Eye pain
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Vascular disorders
Hot flush
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
8.4%
7/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Vascular disorders
Flushing
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
16.7%
1/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
6.1%
2/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
7.2%
6/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
8.4%
7/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
28.6%
2/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Renal and urinary disorders
Dysuria
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Reproductive system and breast disorders
Pelvic pain
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
20.0%
1/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/33 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/6 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/83 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/5 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
14.3%
1/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
0.00%
0/7 • From date of first dose until 30 days post treatment discontinuation for any cause, assessed up to 3 years, 11 months, and 17 days
Incidence and nature of TEAEs and SAEs according to NCI-CTCAE Version 5.0. Adverse Events were collected at the beginning of each cycle, from first dose of trial treatment until approximately 30 days after treatment discontinuation (safety follow up visit).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60