Trial Outcomes & Findings for Mirdametinib + BGB-3245 in Advanced Solid Tumors (NCT NCT05580770)
NCT ID: NCT05580770
Last Updated: 2026-05-01
Results Overview
Safety and tolerability endpoint evaluation via incidence of treatment emergent Adverse Events (TEAEs). TEAE severities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0. AEs were coded using MedDRA Version 27.1.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
23 participants
Primary outcome timeframe
All adverse events were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
Results posted on
2026-05-01
Participant Flow
Participants were enrolled in each Part 1 cohort following safety committee review. Study was terminated after Part 1 Cohort 5 was completed due to intolerance of the combination and no apparent early signs of efficacy. No participants were enrolled in Part 2 of the study.
Participant milestones
| Measure |
Phase 1, Cohort 1 - Dose Escalation
Mirdametinib: Mirdametinib 2mg bid administered orally
BGB-3245: BGB-3245 5mg qd administered orally
|
Phase 1, Cohort 2 - Dose Escalation
Mirdametinib: Mirdametinib 2mg bid administered orally
BGB-3245: BGB-3245 10mg qd administered orally
|
Phase 1, Cohort 3 - Dose Escalation
Mirdametinib: Mirdametinib 2mg bid administered orally
BGB-3245: BGB-3245 20mg qd administered orally
|
Phase 1, Cohort 4 - Dose Escalation
Mirdametinib: Mirdametinib 3mg bid administered orally
BGB-3245: BGB-3245 10mg qd administered orally
|
Phase 1, Cohort 5 - Dose Escalation
Mirdametinib: Mirdametinib 4mg bid administered orally
BGB-3245: BGB-3245 10mg qd administered orally
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
6
|
4
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
1
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
5
|
1
|
2
|
Reasons for withdrawal
| Measure |
Phase 1, Cohort 1 - Dose Escalation
Mirdametinib: Mirdametinib 2mg bid administered orally
BGB-3245: BGB-3245 5mg qd administered orally
|
Phase 1, Cohort 2 - Dose Escalation
Mirdametinib: Mirdametinib 2mg bid administered orally
BGB-3245: BGB-3245 10mg qd administered orally
|
Phase 1, Cohort 3 - Dose Escalation
Mirdametinib: Mirdametinib 2mg bid administered orally
BGB-3245: BGB-3245 20mg qd administered orally
|
Phase 1, Cohort 4 - Dose Escalation
Mirdametinib: Mirdametinib 3mg bid administered orally
BGB-3245: BGB-3245 10mg qd administered orally
|
Phase 1, Cohort 5 - Dose Escalation
Mirdametinib: Mirdametinib 4mg bid administered orally
BGB-3245: BGB-3245 10mg qd administered orally
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
4
|
0
|
2
|
|
Overall Study
Removal from Study
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Some participants did not report initial diagnosis dates
Baseline characteristics by cohort
| Measure |
Phase 1, Cohort 1 - Dose Escalation
n=3 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 5mg administered orally
|
Phase 1, Cohort 2 - Dose Escalation
n=7 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 3 - Dose Escalation
n=6 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 20mg administered orally
|
Phase 1, Cohort 4 - Dose Escalation
n=4 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 3mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 5 - Dose Escalation
n=3 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 4mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
72 years
n=3 Participants
|
56 years
n=7 Participants
|
54 years
n=6 Participants
|
52 years
n=4 Participants
|
41 years
n=3 Participants
|
55 years
n=23 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
13 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
10 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
19 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
14 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
4 participants
n=7 Participants
|
5 participants
n=6 Participants
|
3 participants
n=4 Participants
|
1 participants
n=3 Participants
|
16 participants
n=23 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=3 Participants
|
3 participants
n=7 Participants
|
1 participants
n=6 Participants
|
1 participants
n=4 Participants
|
2 participants
n=3 Participants
|
7 participants
n=23 Participants
|
|
Type of Cancer Diagnosis
Non-small Cell Lung Carcinoma
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=23 Participants
|
|
Type of Cancer Diagnosis
Colorectal Cancer
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=23 Participants
|
|
Type of Cancer Diagnosis
Ovarian Cancer
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=23 Participants
|
|
Type of Cancer Diagnosis
Melanoma
|
2 Participants
n=3 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
9 Participants
n=23 Participants
|
|
Type of Cancer Diagnosis
Pancreatic Cancer
|
1 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=23 Participants
|
|
Type of Cancer Diagnosis
Other
|
0 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=23 Participants
|
|
Time Since Initial Diagnosis
|
100.3 months
n=3 Participants • Some participants did not report initial diagnosis dates
|
63.1 months
n=7 Participants • Some participants did not report initial diagnosis dates
|
33.0 months
n=6 Participants • Some participants did not report initial diagnosis dates
|
14.9 months
n=4 Participants • Some participants did not report initial diagnosis dates
|
68.8 months
n=1 Participants • Some participants did not report initial diagnosis dates
|
60.2 months
n=21 Participants • Some participants did not report initial diagnosis dates
|
|
Time Since First Metastatic Disease
|
68.3 months
n=3 Participants • Some participants did not report/did not have first metastatic disease dates.
|
56.3 months
n=7 Participants • Some participants did not report/did not have first metastatic disease dates.
|
36.1 months
n=5 Participants • Some participants did not report/did not have first metastatic disease dates.
|
7.0 months
n=4 Participants • Some participants did not report/did not have first metastatic disease dates.
|
79.3 months
n=2 Participants • Some participants did not report/did not have first metastatic disease dates.
|
56.3 months
n=21 Participants • Some participants did not report/did not have first metastatic disease dates.
|
|
Lesion Location
Lymph Node
|
2 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=23 Participants
|
|
Lesion Location
Lung
|
0 Participants
n=3 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
11 Participants
n=23 Participants
|
|
Lesion Location
Liver
|
2 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
10 Participants
n=23 Participants
|
|
Lesion Location
Bone
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=23 Participants
|
|
Number of Prior Lines of Cancer Therapy
2
|
0 Participants
n=3 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=23 Participants
|
|
Lesion Location
Other Soft Tissue
|
0 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=23 Participants
|
|
Lesion Location
Other Site
|
1 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
8 Participants
n=23 Participants
|
|
Prior Anti-Cancer Therapy
Yes
|
3 Participants
n=3 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
23 Participants
n=23 Participants
|
|
Prior Anti-Cancer Therapy
No
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=23 Participants
|
|
Prior Radiotherapy
Yes
|
1 Participants
n=3 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
13 Participants
n=23 Participants
|
|
Prior Radiotherapy
No
|
2 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
10 Participants
n=23 Participants
|
|
Number of Prior Lines of Cancer Therapy
1
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=23 Participants
|
|
Number of Prior Lines of Cancer Therapy
3
|
1 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=23 Participants
|
|
Number of Prior Lines of Cancer Therapy
4
|
0 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=23 Participants
|
|
Number of Prior Lines of Cancer Therapy
5
|
1 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=23 Participants
|
|
Number of Prior Lines of Cancer Therapy
6
|
1 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=23 Participants
|
|
Number of Prior Lines of Cancer Therapy
7
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=23 Participants
|
|
Number of Prior Lines of Cancer Therapy
9
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=23 Participants
|
|
History of Prior Cancer Surgery - Indication
Diagnostic
|
0 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=23 Participants
|
|
History of Prior Cancer Surgery - Indication
Therapeutic
|
3 Participants
n=3 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
17 Participants
n=23 Participants
|
|
History of Prior Cancer Surgery - Indication
Missing
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=23 Participants
|
|
History of Prior Cancer Surgery - Complete Resection
Yes
|
3 Participants
n=3 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
15 Participants
n=23 Participants
|
|
History of Prior Cancer Surgery - Complete Resection
No
|
0 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
8 Participants
n=23 Participants
|
|
Type of Mutation
BRAF
|
1 Participants
n=3 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
7 Participants
n=23 Participants
|
|
Type of Mutation
NRAS
|
1 Participants
n=3 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
9 Participants
n=23 Participants
|
|
Type of Mutation
KRAS
|
1 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=23 Participants
|
|
Type of Mutation
HRAS
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=23 Participants
|
|
Type of Mutation
Other
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: All adverse events were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).Population: Safety Population: All participants assigned to the study treatment and have taken at least one dose of study treatment (either Mirdametinib or BGB-3245).
Safety and tolerability endpoint evaluation via incidence of treatment emergent Adverse Events (TEAEs). TEAE severities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0. AEs were coded using MedDRA Version 27.1.
Outcome measures
| Measure |
Phase 1, Cohort 1 - Dose Escalation
n=3 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 5mg administered orally
|
Phase 1, Cohort 2 - Dose Escalation
n=7 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 3 - Dose Escalation
n=6 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 20mg administered orally
|
Phase 1, Cohort 4 - Dose Escalation
n=4 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 3mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 5 - Dose Escalation
n=3 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 4mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1 Overall - Dose Escalation
n=23 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib (of various doses) administered orally
BGB-3245: BGB-3245 (of various doses) administered orally
|
|---|---|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events
With at least one TEAE
|
3 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
23 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With at least one treatment-emergent SAE
|
2 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
16 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With at least one study procedure related TEAE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With at least one TEAE leading to any treatment discontinuation
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
11 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With at least one TEAE related to Mirdametinib
|
2 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
20 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With at least one TEAE related to BGB-3245
|
3 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
21 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With at least one TEAE leading to Mirdametinib dose reduction
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With at least one TEAE leading to BGB-3245 dose reduction
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With at least one TEAE leading to Mirdametinib dose interruption
|
2 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
13 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With at least one TEAE leading to BGB-3245 dose interruption
|
2 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
14 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With a TEAE leading to discontinuation of Mirdametinib
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
10 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With a TEAE leading to discontinuation of BGB-3245
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
10 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With at least one Mirdametinib treatment-emergent AE of special interest
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
|
Incidence of Treatment Emergent Adverse Events
With at least one BGB-3245 treatment-emergent AE of special interest
|
0 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: Safety Population: All participants assigned to the study treatment and have taken at least one dose of study treatment (either Mirdametinib or BGB-3245).
The maximum tolerated dose (MTD) for mirdametinib and BGB-3245 administered as a combination, if any, will be based on safety and tolerability during the first 28 days of treatment in Cycle 1.
Outcome measures
| Measure |
Phase 1, Cohort 1 - Dose Escalation
n=23 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 5mg administered orally
|
Phase 1, Cohort 2 - Dose Escalation
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 3 - Dose Escalation
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 20mg administered orally
|
Phase 1, Cohort 4 - Dose Escalation
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 3mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 5 - Dose Escalation
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 4mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1 Overall - Dose Escalation
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib (of various doses) administered orally
BGB-3245: BGB-3245 (of various doses) administered orally
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (Part 1 Only)
Maximum Tolerated Dose: BGB-3245 (QD) when given in combination with mirdametinib
|
10 mg
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Tolerated Dose (Part 1 Only)
Maximum Tolerated Dose: Mirdametinib (BID) when given in combination with BGB-3245
|
3 mg
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Due to study termination during Phase 1 dose escalation a recommended phase 2 dose was not confirmed
The recommended phase 2 dose (RP2D) for mirdametinib and BGB-3245 administered as a combination will be determined based on safety, tolerability, PK, preliminary anti-tumor efficacy, and other available data.
Outcome measures
| Measure |
Phase 1, Cohort 1 - Dose Escalation
n=23 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 5mg administered orally
|
Phase 1, Cohort 2 - Dose Escalation
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 3 - Dose Escalation
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 20mg administered orally
|
Phase 1, Cohort 4 - Dose Escalation
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 3mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 5 - Dose Escalation
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 4mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1 Overall - Dose Escalation
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib (of various doses) administered orally
BGB-3245: BGB-3245 (of various doses) administered orally
|
|---|---|---|---|---|---|---|
|
Recommended Phase 2 Dose [RP2D] (Part 1 Only)
|
NA Participants
Lack of tolerability and observable events before RP2D could be determined
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Due to study termination, no participants were enrolled in Phase 2 of the study
Preliminary anti-tumor efficacy for the RP2D of mirdametinib and BGB-3245 administered as a combination as assessed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). Objective Response Rate (ORR) defined as the proportion of participants with complete response (CR) + partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From participants' date of first dose of study treatment through end of treatment, an average of 3.5 monthsPopulation: Efficacy Evaluable Population: All treated participants who have a baseline tumor response assessment (screening) and at least one post treatment tumor response assessment.
Preliminary anti-tumor efficacy of mirdametinib and BGB-3245 administered as a combination as assessed by CT or MRI. ORR defined as the proportion of participants with Complete Response (CR) + Partial Response (PR) using RECIST v1.1. Responses were as reported by the investigators.
Outcome measures
| Measure |
Phase 1, Cohort 1 - Dose Escalation
n=3 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 5mg administered orally
|
Phase 1, Cohort 2 - Dose Escalation
n=6 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 3 - Dose Escalation
n=4 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 20mg administered orally
|
Phase 1, Cohort 4 - Dose Escalation
n=4 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 3mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 5 - Dose Escalation
n=2 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 4mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1 Overall - Dose Escalation
n=19 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib (of various doses) administered orally
BGB-3245: BGB-3245 (of various doses) administered orally
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (Part 1 Only)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsDuration of response rate in participants treated with the combination of mirdametinib and BGB-3245, defined as the time from response (CR + PR using RECIST v1.1) to disease progression and/or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: PK analysis as prespecified in the Statistical Analysis Plan, was not done and PK parameter data are not available due to the early termination of the study. Only concentration data is available.
To determine the PK of mirdametinib and BGB-3245 administered as a combination in the eligible participant population. Plasma concentrations of mirdametinib and BGB-3245 will be measured to evaluate systemic exposures (AUC, Cmax, Ctrough, and other PK parameters as data allow).
Outcome measures
| Measure |
Phase 1, Cohort 1 - Dose Escalation
n=3 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 5mg administered orally
|
Phase 1, Cohort 2 - Dose Escalation
n=7 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 3 - Dose Escalation
n=5 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 20mg administered orally
|
Phase 1, Cohort 4 - Dose Escalation
n=4 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 3mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 5 - Dose Escalation
n=2 Participants
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 4mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1 Overall - Dose Escalation
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib (of various doses) administered orally
BGB-3245: BGB-3245 (of various doses) administered orally
|
|---|---|---|---|---|---|---|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
BGB-3245 Cycle 1 Day 1 -Predose
|
0.0 ng/mL
Standard Deviation 0.00
|
0.0 ng/mL
Standard Deviation 0.00
|
0.0 ng/mL
Standard Deviation 0.00
|
0.0 ng/mL
Standard Deviation 0.00
|
0.0 ng/mL
Standard Deviation 0.00
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
BGB-3245 Cycle 1 Day 1-1 hr
|
61.9 ng/mL
Standard Deviation 38.64
|
76.9 ng/mL
Standard Deviation 79.50
|
110.7 ng/mL
Standard Deviation 70.99
|
139.9 ng/mL
Standard Deviation 61.83
|
100.1 ng/mL
Standard Deviation 15.49
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
BGB-3245 Cycle 1 Day 1-2 hr
|
74.9 ng/mL
Standard Deviation 16.62
|
118.3 ng/mL
Standard Deviation 79.66
|
321.2 ng/mL
Standard Deviation 113.73
|
172.3 ng/mL
Standard Deviation 42.62
|
186.0 ng/mL
Standard Deviation 26.87
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
BGB-3245 Cycle 1 Day 1-4 hr
|
54.2 ng/mL
Standard Deviation 7.98
|
100.8 ng/mL
Standard Deviation 53.88
|
325.2 ng/mL
Standard Deviation 96.65
|
166.0 ng/mL
Standard Deviation 102.81
|
166.5 ng/mL
Standard Deviation 14.85
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
BGB-3245 Cycle 1 Day 22- Predose
|
518.0 ng/mL
Standard Deviation 293.09
|
404.7 ng/mL
Standard Deviation 189.47
|
1675.0 ng/mL
Standard Deviation 601.04
|
541.0 ng/mL
Standard Deviation 322.44
|
—
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
BGB-3245 Cycle 2 Day 1 - Predose
|
361.7 ng/mL
Standard Deviation 334.31
|
353.8 ng/mL
Standard Deviation 160.65
|
1300.0 ng/mL
Standard Deviation 84.85
|
486.3 ng/mL
Standard Deviation 232.15
|
—
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
BGB-3245 Cycle 2 Day 1 - 1 hr
|
436.0 ng/mL
Standard Deviation 370.99
|
498.2 ng/mL
Standard Deviation 276.51
|
1350.0 ng/mL
Standard Deviation 70.71
|
558.7 ng/mL
Standard Deviation 307.00
|
—
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
BGB-3245 Cycle 2 Day 1 - 2 hr
|
377.3 ng/mL
Standard Deviation 343.60
|
501.8 ng/mL
Standard Deviation 374.16
|
1325.0 ng/mL
Standard Deviation 162.63
|
606.3 ng/mL
Standard Deviation 341.03
|
—
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
BGB-3245 Cycle 2 Day 1 - 4 hr
|
305.7 ng/mL
Standard Deviation 195.88
|
365.8 ng/mL
Standard Deviation 257.11
|
1225.0 ng/mL
Standard Deviation 190.92
|
406.0 ng/mL
Standard Deviation 163.72
|
—
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
BGB-3245 Cycle 3 Day 1 -Predose
|
596.3 ng/mL
Standard Deviation 393.52
|
277.6 ng/mL
Standard Deviation 271.99
|
1051.0 ng/mL
Standard Deviation 281.43
|
9.1 ng/mL
|
—
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
Mirdametinib Cycle 1 Day 1- Predose
|
0.0 ng/mL
Standard Deviation 0.00
|
0.0 ng/mL
Standard Deviation 0.00
|
0.0 ng/mL
Standard Deviation 0.00
|
0.0 ng/mL
Standard Deviation 0.00
|
0.0 ng/mL
Standard Deviation 0.00
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
Mirdametinib Cycle 1 Day 1- 1 hr
|
82.9 ng/mL
Standard Deviation 8.06
|
48.0 ng/mL
Standard Deviation 24.75
|
59.9 ng/mL
Standard Deviation 25.01
|
115.4 ng/mL
Standard Deviation 44.31
|
163.5 ng/mL
Standard Deviation 40.31
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
Mirdametinib Cycle 1 Day 1- 2 hr
|
39.2 ng/mL
Standard Deviation 14.96
|
34.8 ng/mL
Standard Deviation 14.73
|
36.6 ng/mL
Standard Deviation 9.28
|
48.0 ng/mL
Standard Deviation 12.34
|
64.6 ng/mL
Standard Deviation 14.28
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
Mirdametinib Cycle 1 Day 1- 4 hr
|
18.2 ng/mL
Standard Deviation 7.04
|
14.0 ng/mL
Standard Deviation 4.32
|
13.6 ng/mL
Standard Deviation 3.04
|
24.9 ng/mL
Standard Deviation 5.59
|
23.6 ng/mL
Standard Deviation 3.46
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
Mirdametinib Cycle 1 Day 22- Predose
|
35.4 ng/mL
Standard Deviation 2.93
|
15.7 ng/mL
Standard Deviation 7.18
|
13.0 ng/mL
Standard Deviation 4.17
|
38.9 ng/mL
Standard Deviation 11.88
|
—
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
Mirdametinib Cycle 2 Day 1- Predose
|
19.2 ng/mL
Standard Deviation 16.86
|
10.9 ng/mL
Standard Deviation 7.33
|
13.1 ng/mL
Standard Deviation 2.40
|
28.9 ng/mL
Standard Deviation 3.74
|
—
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
Mirdametinib Cycle 2 Day 1- 1 hr
|
90.1 ng/mL
Standard Deviation 66.50
|
81.5 ng/mL
Standard Deviation 72.15
|
48.0 ng/mL
Standard Deviation 21.78
|
143.0 ng/mL
Standard Deviation 14.42
|
—
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
Mirdametinib Cycle 2 Day 1- 2 hr
|
56.8 ng/mL
Standard Deviation 18.86
|
46.9 ng/mL
Standard Deviation 27.25
|
62.0 ng/mL
Standard Deviation 41.51
|
100.4 ng/mL
Standard Deviation 2.95
|
—
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
Mirdametinib Cycle 2 Day 1- 4 hr
|
36.2 ng/mL
Standard Deviation 15.79
|
26.2 ng/mL
Standard Deviation 11.38
|
24.1 ng/mL
Standard Deviation 7.00
|
52.0 ng/mL
Standard Deviation 8.64
|
—
|
—
|
|
Change in Plasma Concentrations of Mirdametinib and BGB-3245
Mirdametinib Cycle 3 Day 1- Predose
|
23.8 ng/mL
Standard Deviation 13.60
|
10.3 ng/mL
Standard Deviation 11.11
|
9.2 ng/mL
Standard Deviation 4.06
|
0 ng/mL
Standard Deviation 0.00
|
—
|
—
|
Adverse Events
Phase 1, Cohort 1 - Dose Escalation
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1, Cohort 2 - Dose Escalation
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 1, Cohort 3 - Dose Escalation
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase 1, Cohort 4 - Dose Escalation
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1, Cohort 5 - Dose Escalation
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1 Overall
Serious events: 16 serious events
Other events: 22 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Phase 1, Cohort 1 - Dose Escalation
n=3 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 5mg administered orally
|
Phase 1, Cohort 2 - Dose Escalation
n=7 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 3 - Dose Escalation
n=6 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 20mg administered orally
|
Phase 1, Cohort 4 - Dose Escalation
n=4 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 3mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 5 - Dose Escalation
n=3 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 4mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1 Overall
n=23 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib and BGB-3245 of various dosing
|
|---|---|---|---|---|---|---|
|
INFECTIONS AND INFESTATIONS
Cellulitis
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INFECTIONS AND INFESTATIONS
Sinusitis
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INFECTIONS AND INFESTATIONS
COVID-19
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INFECTIONS AND INFESTATIONS
Pneumonia
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INFECTIONS AND INFESTATIONS
Sepsis
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Pyrexia
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
2/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
17.4%
4/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GASTROINTESTINAL DISORDERS
Abdominal pain
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GASTROINTESTINAL DISORDERS
Large intestinal obstruction
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INVESTIGATIONS
Blood creatine phosphokinase increased
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INVESTIGATIONS
Platelet count decreased
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Dehydration
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Hyponatraemia
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Malnutrition
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
PSYCHIATRIC DISORDERS
Confusional state
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
PSYCHIATRIC DISORDERS
Delirium
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
PSYCHIATRIC DISORDERS
Hallucination
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
RENAL AND URINARY DISORDERS
Acute kidney injury
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Dyspnoea
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Rash maculo-papular
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
CARDIAC DISORDERS
Sinus tachycardia
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Rhabdomyolysis
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
Tumour pain
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
NERVOUS SYSTEM DISORDERS
Syncope
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
4.3%
1/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
Other adverse events
| Measure |
Phase 1, Cohort 1 - Dose Escalation
n=3 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 5mg administered orally
|
Phase 1, Cohort 2 - Dose Escalation
n=7 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 3 - Dose Escalation
n=6 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 2mg administered orally
BGB-3245: BGB-3245 20mg administered orally
|
Phase 1, Cohort 4 - Dose Escalation
n=4 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 3mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1, Cohort 5 - Dose Escalation
n=3 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib: Mirdametinib 4mg administered orally
BGB-3245: BGB-3245 10mg administered orally
|
Phase 1 Overall
n=23 participants at risk
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Mirdametinib and BGB-3245 of various dosing
|
|---|---|---|---|---|---|---|
|
GASTROINTESTINAL DISORDERS
Diarrhoea
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
42.9%
3/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
2/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
100.0%
4/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
66.7%
2/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
52.2%
12/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GASTROINTESTINAL DISORDERS
Nausea
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
42.9%
3/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
2/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
75.0%
3/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
66.7%
2/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
47.8%
11/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GASTROINTESTINAL DISORDERS
Vomiting
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
28.6%
2/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
2/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
75.0%
3/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
30.4%
7/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GASTROINTESTINAL DISORDERS
Abdominal pain
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GASTROINTESTINAL DISORDERS
Constipation
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
42.9%
3/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GASTROINTESTINAL DISORDERS
Gastrooesophageal reflux disease
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GASTROINTESTINAL DISORDERS
Stomatitis
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GASTROINTESTINAL DISORDERS
Abdominal distension
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GASTROINTESTINAL DISORDERS
Dry mouth
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypokalaemia
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
2/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
50.0%
2/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
26.1%
6/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypomagnesaemia
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
2/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
21.7%
5/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Decreased appetite
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
42.9%
3/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
21.7%
5/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypoalbuminaemia
|
66.7%
2/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
17.4%
4/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Dehydration
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypocalcaemia
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypophosphataemia
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Hypercalcaemia
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
METABOLISM AND NUTRITION DISORDERS
Hyponatraemia
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INVESTIGATIONS
Blood creatine phosphokinase increased
|
66.7%
2/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
42.9%
3/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
66.7%
4/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
47.8%
11/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INVESTIGATIONS
Aspartate aminotransferase increased
|
66.7%
2/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
50.0%
2/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
26.1%
6/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INVESTIGATIONS
Blood creatinine increased
|
66.7%
2/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INVESTIGATIONS
Alanine aminotransferase increased
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INVESTIGATIONS
Blood bilirubin increased
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INVESTIGATIONS
Blood alkaline phosphatase increased
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INVESTIGATIONS
Platelet count decreased
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Dermatitis acneiform
|
100.0%
3/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
50.0%
2/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
34.8%
8/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Rash maculo-papular
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
42.9%
3/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
26.1%
6/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Rash
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
2/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
17.4%
4/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Pruritus
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
42.9%
3/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Dry skin
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Fatigue
|
66.7%
2/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
71.4%
5/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
2/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
66.7%
2/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
52.2%
12/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Oedema peripheral
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
50.0%
2/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
17.4%
4/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Pyrexia
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
2/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Influenza like illness
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Chills
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
2/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Dyspnoea
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
28.6%
2/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
17.4%
4/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Oropharyngeal pain
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
28.6%
2/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Cough
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
28.6%
2/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Epistaxis
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Wheezing
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
28.6%
2/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INFECTIONS AND INFESTATIONS
Sinusitis
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
28.6%
2/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
INFECTIONS AND INFESTATIONS
Candida infection
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
NERVOUS SYSTEM DISORDERS
Headache
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
57.1%
4/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
26.1%
6/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
NERVOUS SYSTEM DISORDERS
Dizziness
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Muscular weakness
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Back pain
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Pain in extremity
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
33.3%
2/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Anaemia
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
13.0%
3/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
EYE DISORDERS
Vision blurred
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
PSYCHIATRIC DISORDERS
Anxiety
|
33.3%
1/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
14.3%
1/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
PSYCHIATRIC DISORDERS
Confusional state
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
28.6%
2/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
|
CARDIAC DISORDERS
Sinus tachycardia
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/7 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
16.7%
1/6 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
25.0%
1/4 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
0.00%
0/3 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
8.7%
2/23 • All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months).
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60